Comparison of Two Sitting Durations During Saddle Anesthesia on Discharge Readiness in Perianal Surgery

Comparison of Two Sitting Durations During Saddle Anesthesia on Discharge Readiness in Perianal Surgery: A Randomized Controlled Trial

Most minor perianal surgeries are performed as day-case procedures requiring rapid recovery and effective symptom control. Saddle block anesthesia (SBA) provides reliable perineal anesthesia with minimal hemodynamic and motor effects, promoting faster recovery than general anesthesia. However, the duration of sitting after intrathecal injection influences anesthetic spread, and the optimal sitting time to balance adequate anesthesia with early discharge remains unclear.

Study Overview

• Status: Recruiting
• Conditions: Quality of Recovery (QoR-15); Saddle Block Anesthesia; Readiness of Discharge
• Intervention / Treatment: Other: 5-min sitting duration after SBA; Other: 8-min sitting duration after SBA

Detailed Description

Spinal anesthesia will be administered in the sitting position at the L4-5 interspinous space using 7.5 mg of 0.5% hyperbaric bupivacaine.

Hemodynamic data (heart rate and blood pressure) will be recorded at baseline, then at 2 min interval after SBA until the end of surgery.

Postoperative pain will be assessed using the numeric rating scale at the post anesthesia care unit (PACU) and before discharge. If the numeric rating scale (NRS) > 3 or at any time if demanded by the patient, 15 mg of IV ketorolac will be given if persisted titrated doses of nalbuphine will be given In case of postoperative nausea and vomiting, 4 mg of IV ondansetron will be given.

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maha Mostafa; Phone Number: +201000365115; Email: maha.mostafa@cu.edu.eg

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt
      • Recruiting
      • Cairo University
      • Contact: ahmed Hasanin, Lecturer; Phone Number: +2010095076954; Email: ahmedmohamedhasanin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients (21-65 years), ASA I-III undergoing perianal surgery.

Exclusion Criteria:

• Severe cardiac morbidities (impaired contractility with ejection fraction < 40%, heart block, arrhythmias, tight valvular lesions)
• Contraindication to neuraxial anesthesia such as coagulopathy and local infection
• Pregnant or lactating women,
• Allergy of any of the study drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 5-min group	Other: 5-min sitting duration after SBA; Patients will remain seated for 5 min after local anesthetic injection
Active Comparator: 8-min group	Other: 8-min sitting duration after SBA; Patients will remain seated for 8 min after local anesthetic injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to readiness for discharge	Patients will be considered ready for discharge when the modified Post Anaesthetic Discharge Scoring System (PADSS) >9	During the first 24 hour postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to void	time in min until patient able to urinate	from SBA till 24 hour postoperatively
time to ambulation	time in min from SBA until patient able to move independently	from SBA till 24 hour postoperatively
quality of recovery	using QOR-15 score; 15-item questionnaire designed to assess a patient's quality of recovery following surgery and anesthesia It measures recovery across five key domains: physical comfort, pain, physical independence, psychological support, and emotional state. Scoring Range: Each of the 15 questions is rated on an 11-point scale (0-10). The total score ranges from 0 (extremely poor recovery) to 150 (excellent recovery).	at the end of 24 hour after surgery

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: March 8, 2026
• First Submitted That Met QC Criteria: March 8, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 15, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: MS-665-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: data associated with this research are available form the PI upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No